510(k) K972030 ยท JWX Kit, Screening, Staphylococcus Aureus
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
| Applicant | Oxoid , Ltd., Basingstoke, GB |
| Decision | Substantially Equivalent, Sep 8, 1997 |
| Received | Jun 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2009 | Remel, Inc Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit.
Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain po Terminated |
JWX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.